Merck has announced the initiation of two global pivotal Phase III trials - EVOLUTION RMS 1 and 2 - which study the efficacy and safety of evobrutinib.
The drug, an oral and highly selective Bruton’s Tyrosine Kinase (BTK) inhibitor, is for adult patients with relapsing multiple sclerosis (RMS).
The Phase III trial is being initiated following the results of the Phase II clinical trial, which met its primary endpoint over 24 weeks of treatment. Further data show that the effect on relapse reduction observed at Week 24 was also maintained through 48 weeks.
The studies are multicenter, randomised, parallel group, double-blind, active-controlled studies comparing a twice-daily dosing of the drug with interferon beta-1a given intramuscularly once a week.
Dr. Xavier Montalban, professor of medicine and department division director, neurology, University of Toronto explained that “Even with the most effective therapies for RMS, more than 50% of patients experience clinical or subclinical disease activity, therefore a need still exists for novel oral therapies that address MS pathobiology differently. We look forward to seeing the outcomes of this clinical programme following the promising Phase II results.”
The company confirmed that trial recruitment is currently underway with the goal of 1900 patients enrolled, and a target completion date in June 2023.
MS is a chronic, inflammatory condition of the central nervous system and is the most common non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide.